K192310 is an FDA 510(k) clearance for the Flap Fixator, Burr Hole Cover. This device is classified as a Cover, Burr Hole (Class II - Special Controls, product code GXR).
Submitted by Ossaware Biotech Co., Ltd. (Shenkang Hsiang, TW). The FDA issued a Cleared decision on June 3, 2020, 282 days after receiving the submission on August 26, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5250.
| 510(k) Number | K192310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2019 |
| Decision Date | June 03, 2020 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXR - Cover, Burr Hole |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5250 |